Systems and methods for sling delivery and placement

ABSTRACT

Devices and methods for delivering and placing a surgical sling without resorting to an abdominal incision are disclosed.

RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.10/832,653, filed on Apr. 26, 2004 now U.S. Pat. No. 8,012,080, whichclaims priority to U.S. Provisional Application No. 60/465,722, filedApr. 25, 2003, the specification of which is incorporated herein byreference in its entirety.

BACKGROUND OF THE INVENTION

Stress urinary incontinence (SUI) affects primarily women, but also men,and is generally caused by two conditions, intrinsic sphincterdeficiency (ISD) and hypermobility. These conditions may occurindependently or in combination. In ISD, the urinary sphincter valve,located within the urethra, fails to close properly (coapt), causingurine to leak out of the urethra during stressful activity.Hypermobility is a condition in which the pelvis floor is distended,weakened or damaged, causing the bladder neck and proximal urethra torotate and descend in response to increases in intra-abdominal pressure(e.g., due to sneezing, coughing, straining, etc.). As a result, thepatient's response time becomes insufficient to promote urethral closureand, consequently, the patient suffers from urine leakage and/or flow.

A popular treatment of SUI uses a surgical sling placed under thebladder neck or the mid-urethra to provide a urethral platform.Placement of the sling limits the endopelvis fascia drop while providingcompression to the urethral sphincter to improve coaptation. Themid-urethral sling is traditionally affixed using a bone anchoringmethod. Recent advances in surgical techniques have demonstrated theeffectiveness of anchorless approaches toward mid-urethra slingstabilization. However, these anchorless techniques typically requireincisions in addition to those made in the vaginal wall. By way ofexample, some procedures require abdominal incisions, while othersrequire ishiopubic incisions.

Accordingly, there is a need for an improved approach to sling placementthat simplifies the procedure and reduces trauma to the patient.

SUMMARY OF THE INVENTION

The systems and methods described herein are generally directed to thedelivery and application of an implant to an anatomical site in apatient. More particularly, in one embodiment, the systems and methodsof the invention are suitable for sub-urethral implantation of animplantable sling into the periurethral tissue, without the need forabdominal or ishiopubic incisions. According to a further embodiment,the invention avoids any need for bone anchors to anchor the sling inplace.

In one aspect, the invention provides a system for treating urinaryincontinence in a patient, including: a first elongated delivery devicehaving a proximal end and a distal end, a first aperture located nearthe distal end, a second aperture located near the proximal end, and alumen extending between the first and second apertures; and a slingassembly including a sling at least partially enclosed by a sleeve, thesling assembly having a first end threaded through into the firstaperture, through the lumen and out the second aperture of the firstelongated delivery device.

According to one embodiment, the sleeve is longer than the sling and aportion of the sleeve not enclosing the sling threads into the firstaperture, through the lumen and out the second aperture. According toone configuration, the first elongated delivery device includes afrustoconical tip as its distal end, the conical tip being sufficientlypointed to pierce and tunnel through tissue. In another configuration,the tip at the distal end of the delivery device is rounded. Accordingto an alternative configuration, the first aperture is located at atermination of the distal end of the first elongated delivery device. Inanother configuration, the first aperture is located in a side wall nearthe distal end of the first elongated delivery device. In a similarfashion the second aperture may be located at a termination of theproximal end of the first elongated delivery device, or alternatively,in a side wall near the proximal end of the first elongated deliverydevice.

The sling assembly, preferably, includes a tabbed spacer located along abottom surface of the sleeve, and engages a portion of the bottomsurface of the sleeve to inhibit the sleeve from sliding off the sling,without first cutting through the tabbed spacer. In one embodiment, thetabbed spacer engages a looped portion of the bottom surface of thesleeve. In an alternative embodiment, the tabbed spacer engages sleevetails of the bottom surface of the sleeve.

In some embodiments, only the sleeve end extends into the firstelongated delivery device. However, in other embodiments, the sling hasa first end that extends into the lumen of the first elongated deliverydevice.

According to another feature, the system includes an operator actuatablecutting device located in the lumen for cutting off a portion of atleast one of the sling and the sleeve. In one configuration, theactuator operatively connects to the cutter and extends from the cutterthrough the lumen and out the second aperture, the cutter being actuatedby pushing the actuator in a distal direction.

According to one configuration, the first elongated delivery deviceincludes a handle located near its proximal end. In a relatedconfiguration, the first elongated delivery device includes a shafthaving a first straight portion extending distally along an axis from adistal end of the handle and a curved portion first curving away fromthe axis and then curving back toward the axis. In some embodiments, thecurved portion does not extend to the axis subsequent to curving backtoward the axis. However, in other embodiments, the curved portionextends to or crosses the axis subsequent to curving back toward theaxis.

In some embodiments, the system includes two elongated delivery devices,sometimes referred to below as delivery legs. According to one suchembodiment, the system includes, a second elongated delivery devicehaving a proximal end and a distal end, a first aperture located nearthe distal end, a second aperture located near the proximal end, and alumen extending between the first and second apertures, and the slingassembly has a second end threaded through into the first aperture,through the lumen and out the second aperture of the second elongateddelivery device.

In one aspect, the system includes a handle having proximal and distalends, wherein the proximal ends of the first and second elongateddelivery devices intersect with the distal end of the handle to form asubstantially “Y”-shaped delivery system configuration. In oneembodiment, the proximal ends of the first and second elongated deliverydevices attach to the distal end of the handle. In another embodiment,the proximal ends of the first and second elongated delivery devices areformed integrally with the distal end of the handle. In a furtherembodiment, the first and second elongated delivery devices aresufficiently flexible for an operator to squeeze them together during asling implantation procedure. According to one feature, the first andsecond elongated delivery devices are sufficiently resilient tosubstantially return to an original shape in response to the operatorremoving a squeezing force. In a related feature, the handle issufficiently flexible for an operator to squeeze the first and secondelongated delivery devices together.

According to another aspect, the invention does not employ a sleeve topartially enclose the sling. In this aspect, the system includes; afirst elongated delivery device having a proximal end and a distal end,a first aperture located near the distal end, a second aperture locatednear the proximal end, and a lumen extending between the first andsecond apertures; and a sling assembly including a sling having firstand second ends, at least the first end being operatively associatedwith the distal end of the first elongated delivery device. According toone embodiment, the first end attaches to a suture, and the suturethreads through the first aperture located near the distal end of thedelivery device. In a further embodiment, the suture passes through thefirst aperture near the distal end through the lumen and out the secondaperture near the proximal end.

According to a related embodiment, the system includes an engagingdevice attached to an end of the suture, and a receptacle near thedistal end of the first delivery device for engaging with the engagingdevice of the sling. In operation, the engaging device is engaged with adistal end of a delivery device and inserted by the distal end of thedelivery device through an incision in a vaginal wall of a patient alonga first side of the patient's urethra to position the first end of thesling in periurethral tissue on the first side of the patient's urethra,without making any abdominal or ishiopubic incisions. Then the engagingdevice, along with the first end of the sling assembly, is disengagedfrom the distal end of the delivery device which is withdrawn.

In another aspect, the invention provides a method for implanting asling under a urethra in a body of a patient, the method comprising:threading an end of a sleeve at least partially enclosing a slingthrough into an aperture near a distal end of delivery device, through alumen extending along at least a portion of a length of the deliverydevice, and out an aperture near a distal end of the delivery device;inserting the distal end of the delivery device through an incision in avaginal wall along a first side of the urethra; sliding the sleeve offthe sling through the lumen of the delivery device out of the body ofthe patient; and leaving the sling in the body of the patient to supportthe urethra. According to one embodiment, the method includespositioning an end of the sling in front of the pubic bone. In analternative embodiment, the method includes positioning an end of thesling behind the pubic bone. In another embodiment, the method includespositioning an end of the sling near the pubic bone. In otherembodiments, the method includes positioning an end of the sling near orthrough an obturator foramen.

Further features and advantages of the invention will be apparent fromthe following description of preferred embodiments and from the claims.

BRIEF DESCRIPTION OF THE DRAWINGS

The following figures depict certain illustrative embodiments of theinvention in which like reference numerals refer to like elements. Thesedepicted embodiments may not be drawn to scale and are to be understoodas illustrative of the invention and not as limiting in any way.

FIG. 1 depicts a sling delivery system for delivering a sling to ananatomical site of a patient according to an illustrative embodiment ofthe invention;

FIG. 2 is a cross-sectional view taken along the line II-II of the slingdelivery system of FIG. 1;

FIG. 3 depicts a mesh sling illustrative of a type that may be employedwith the sling delivery system of FIG. 1;

FIG. 4 is a cross-sectional view, along the line IV-IV of theillustrative sling delivery system of FIG. 1;

FIGS. 5A-5C schematically depicts an illustrative process for assemblingthe sling delivery system of FIG. 1;

FIG. 6 depicts a sling delivery system for delivering a sling to ananatomical site of a patient according to another illustrativeembodiment of the invention;

FIGS. 7A-7C schematically depict an illustrative placement of a sling atan anatomical site of a female patient using the sling delivery systemof FIG. 1;

FIGS. 8A-8C schematically depict an illustrative placement of a sling atan anatomical site of a male patient using the illustrative slingdelivery system of FIG. 1;

FIG. 9 depict a sling delivery system according to an alternativeembodiment of the invention;

FIG. 10 depicts a sling delivery system according to another alternativeembodiment of the invention;

FIG. 11 depicts a sling delivery system according to another alternativeembodiment of the invention;

FIG. 12 depicts a sling delivery system according to another alternativeembodiment of the invention;

FIG. 13 depicts a sling delivery system according to another alternativeembodiment of the invention; and

FIG. 14 shows another alternative sling delivery system for placing asling.

ILLUSTRATIVE DESCRIPTION

In general, the invention is directed to systems and methods for thetreatment of urinary incontinence. In one illustrative embodiment, theinvention provides simplified systems and methods for delivering andplacing a medical implant to an anatomical site of a patient, withreduced trauma to the patient. In a preferred embodiment, the medicalimplant is a sling for treating urinary incontinence and it is deliveredto the periurethral tissues of either a female or male patient.According to one advantage, the systems and methods of the inventionavoid the need for any abdominal incisions during sling placement.According to a further advantage, the invention also avoids the need forany ishiopubic incisions during sling placement. According to a furtherfeature, the invention also avoids the need for any bone anchors toanchor the sling in place.

FIG. 1 shows a sling delivery system 10 according to an illustrativeembodiment of the invention. The sling delivery system 10 includesdelivery devices 12 a and 12 b and a sling assembly 14. Referring alsoto FIGS. 3 and 5C, the sling assembly 14 includes a sling 16 and asleeve 18. The sleeve 18 is formed from a flexible material, such as aflexible polymer plastic, and partially encloses the sling 16. Thesleeve 18 includes an upper surface 20 and a lower surface 22. Referringalso to FIG. 4, an opening 19, located at a midpoint 24 of the uppersurface 20 of the sleeve 18, exposes the entire width of the sling 16.

Referring also to FIG. 3, in some illustrative embodiments the sling 16has a length of about 10 to about 15 cm (about 4-6 inches) and a widthof about 1 to about 3 cm, though the length and width of the sling 16can be adapted to the body part of the patient that requires support. Byway of example, in some embodiments the sling 16 is about 45 cm inlength. The sling 16 may be rectangular, as illustrated in FIG. 3, orhave another suitable shape. The sling 16 may have a uniform thicknessover the entire length and/or width of sling 16. Alternatively, thethickness can be suitably varied at one or more locations. The thicknessof the sling 16 material may range from about 0.02 to about 0.10 cm. Inone embodiment, the sling 16 is a strip of mesh with any of a numberand/or configurations of knits, weaves, or braids.

The sling 16 may be fabricated from any of a number of biocompatiblematerials, such as nylon, polyethylene, polyester, polypropylene,fluoropolymers, copolymers thereof, combinations thereof, or othersuitable synthetic material(s). The material may be, for example, asynthetic material that is absorbable by the patient's body. Suitableabsorbable synthetic materials can include polyglycolic acid, polylacticacid, and other suitable absorbable synthetic materials. Alternatively,the material for the sling 16 may be derived from mammalian tissue(s) ora combination of mammalian tissue(s) and synthetic material(s). Thesling material may be fabricated from one or more yarns, which yarns maybe made from one or more materials. The sling 16 may incorporate or becoated with one or more agents to provide a therapeutic effect, forexample, to reduce discomfort, to reduce the chance of infection and/orto promote tissue growth.

Referring back to FIG. 1 and also to FIG. 3, in one embodiment, the edgeregions of the sling 16 can be configured differently depending on theirintended placement in the body of the patient. For example, a midsection32 of the sling 16 is typically located where an anatomical site, suchas a midurethral or bladder neck location in the periurethral tissue,needs to be supported. In one illustrative embodiment, the midsection 32of the sling 16 has smooth or rounded edges, hereinafter also referredto as “non-tanged.” According to a further illustrative embodiment,other sections of the sling 16 may include tangs (e.g., sharpprojections or frayed edges) 34. The tangs 34 are generally useful foranchoring the sling 16 and encouraging tissue growth into the sling 16.Anchoring the sling 16 in this manner generally obviates the need foradditional sutures to hold the sling 16 in place.

The tanged and non-tanged edges of sling 16 can be formed in a pluralityof ways. For example, the sling 16 can be cut from a woven sheet, inwhich case the edges would be initially tanged along the entire lengthof the sling 16. One or more non-tanged sections may be formed by anyprocess that smoothes, rounds or removes the sharp edges of the tangs34. For example, the tangs 34 may be heat-smoothed by burning or meltingthe tangs 34. In one embodiment, the non-tanged section 32 has a lengthof about 1 to about 5 cm, preferably about 2 to about 2.5 cm, on eitheror both sides of the center line 24. Providing one or more non-tangedsections, which may be in close proximity to a sensitive anatomical sitein the patient, can enhance the comfort level of the patient and reducethe potential for the edges of the tangs to erode or irritate theurethra.

Alternatively, the sling 16 can be produced from a woven tape having theapproximate finished width of the sling 16. The smooth sides of the tapecan then be trimmed off to produce the tanged sections 34.

In the illustrative embodiment, the sling 16 terminates at free ends 16a and 16 b. According to the illustrative embodiment, the sling 16,including both free ends 16 a and 16 b, does not connect to the sleeve18 or anything else. This feature enables a medical operator to pull onthe ends 18 a and 18 b of the plastic sleeve 18 during placement of thesling 16, without risk of stretching, curling or otherwise deforming thesling 16. As shown in FIG. 1, in some embodiments, the sling 16 is longenough so that the sling ends 16 a and 16 b extend through the deliverydevices 12 a and 12 b. However, as shown in FIG. 4, in a preferredembodiment, the sling 16 is sized so that its ends 16 a and 16 b do notextend into delivery devices 12 a and 12 b.

A tabbed spacer 26 is located at a midpoint 24 of the lower surface 22of the sleeve 18, and encloses a looped portion 28 of the bottom surface22 of the sleeve 18. In one embodiment, the tabbed spacer 26 has a colordifferent from that of the sleeve 18 or of the sling 16 to allow readyidentification during the sling placement procedure. The tabbed spacer26 can be used during implantation as a visual aid to placement of thesling 16.

As discussed in detail below with respect to FIG. 5, according to onefeature, the tabbed spacer 26 is formed as cylinder. The looped portion28 of the bottom surface 22 of the sleeve is fitted into the cylinder,and the cylinder is then flattened over the looped portion 28 andaffixed to the looped portion 28, for example, using heat bonding, orany other suitable bonding approach. The tabbed spacer 26 engages thelooped portion 28 of the bottom surface 22 of the sleeve 18 andprohibits the sleeve 18 from sliding off, or otherwise being removedfrom, the sling 16 during sling placement. According to the illustrativeembodiment, the tabbed spacer 26 is cut across the center aperture 30 toenable the sleeve 18 to be slid off the sling 16. According to onefeature, the tabbed spacer 26 ensures that the sleeve 18 does not slideoff the sling 16 simply by applying a pulling force, such as thatapplied to the sleeve ends 18 a and 18 b by a medical operator duringsling placement. After the sling assembly 14 is positioned within thepatient, a cut is made through the center aperture 30 of the tabbedspacer 26, and thus through the looped portion 28 of the bottom surface22 of the sleeve 18. The sleeve 18 can then be slid off of the sling 18and out of the body of the patient by pulling on the sleeve ends 18 aand 18 b. Although the bottom surface 22 is described here as beingcontinuous, as discussed below with respect to FIG. 5, in variousalternative embodiments, it may be divided, for example at its center24, and inserted into the tabbed spacer 26 as two separated tails,rather than a continuous looped portion 28.

FIG. 4 is a cross-sectional view of the sling delivery system 10, takenalong the line IV-IV of FIG. 1. Referring to FIGS. 1 and 4, the twodelivery devices 12 a and 12 b, preferably, have substantially identicalstructures. Referring to FIGS. 1 and 2, the illustrative deliverydevices 12 a and 12 b are formed as tubes or cylinders that definelumens 36 a and 36 b, respectively. In one illustrative embodiment, thelumen 36 a extends from a radial aperture 38 a to a first end aperture40 a located at a proximal end 11 a of the delivery device 12 a. In someembodiments, the distal end 13 a of the delivery device 12 a is closed.However, in alternative embodiments, the lumen 36 a also extends to asecond end aperture 42 a in the distal end 13 a of the delivery device12 a. In a similar fashion, the lumen 36 b extends from a radialaperture 38 b to a first end aperture 40 b at the proximal end 11 b ofthe delivery device 12 b, and the distal end 13 b of the delivery device12 b is closed. As in the case of the delivery device 12 a, the lumen 36b may also extends to a second end aperture 42 b in the distal end 13 bof the delivery device 12 b. The delivery devices 12 a and 12 b maytaper towards their respective distal ends 13 a and 13 b, andoptionally, may come to a conical tip sufficient for dilation of andtunneling through tissue. Additionally, the delivery devices 12 a and 12b may be straight, curved, or have a combination of straight and curvedsections.

As shown in FIG. 4, when assembled, section 18 c of the sleeve 18threads into the radial aperture 38 a through the lumen 36 a and out theend aperture 40 a of the delivery device 12 a, while section 18 d of thesleeve 18 threads into the radial aperture 38 b through the lumen 36 band out the end aperture 40 b of the of the delivery device 12 b. Asdiscussed below with respect to FIGS. 7A-7C, a medical operator may pullon the sleeve ends 18 a and 18 b extending from the delivery devices 12a and 12 b, subsequent to cutting through the tabbed spacer 26, and thuscutting through the looped portion 28 of the bottom surface 22 of thesleeve 18, to slide the sleeve 18 off the sling 16 through the lumens 36a and 36 b.

The delivery devices 12 a and 12 b can assume a variety ofcross-sectional shapes. Referring to FIG. 2, the cross section of thedelivery device 12 a, taken along line II-II is oval in shape, and morepreferably circular in shape. However, in alternative embodiments, anysuitable cross-sectional shape may be employed. Additionally,cross-sections taken at various points along the length of the deliverydevice 12 a may vary in size and/or shape. According to the illustrativeembodiment, the delivery device 12 b has a substantially identicalcross-section to the delivery device 12 a.

Preferably, the delivery devices 12 a and 12 b are made of biocompatiblematerials, which can include, for example, polyethylene/ethylene vinylacetate (EVA) blend, polyethylene, polyester, nylon, polypropylene,thermoplastic fluorinated ethylene propylene (FEP), TFP, stainlesssteel, malleable metal or any combination of these materials.

The sleeve 18 may be made, for example, from one or more absorbentmaterials, such as a sponge-like material, that can optionally bepre-soaked in a drug solution, for example, in an antibiotic solution.In another embodiment, the sleeve 18 may be made from a non-wettablematerial, such as polypropylene, polyethylene, polyester,polytetrafluoroethylene (available from DuPont Corporation, Wilmington,Del., under the trademark TEFLONO), TYVEK V. MYLAR 0, or co-polymersthereof. The non-wettable materials can also be pretreated with atherapeutically effective drug coating. The sleeve 18 can be transparentso that an operator will be able to see the implantable sling 16 insidethe sleeve 18.

FIG. 5 shows schematically an exemplary process for assembling the slingassembly 14. As shown in FIG. 5A, beginning at the center line 24, aportion 48 of the top surface 20 of the sleeve 18 is stripped off to anedge 50 to create the gap 19 in the top surface 20 shown in FIG. 4. Asshown in FIG. 5B, in the case where the sleeve 18 is formed as twosleeve halves, the procedure of FIG. 5A, results in sleeve tail portions55. In the case of the sleeve 18 being formed with a unitary lowersurface 22, the procedure of FIG. 5A results in forming the first halfof the looped portion 28, shown in FIG. 5C. The same process is repeatedby stripping of a similar section of the upper surface 20 of the sleeve18 to an edge 52. As shown in FIG. 5C, the sling end 16 a is theninserted into the respective lumen 54 a formed between the upper 20 andlower 22 surfaces of the sleeve 18. Similarly, the sling end 16 b isinserted into the lumen 54 b. Then, the looped portion 28 or the tailportions 55, as the case may be, are inserted into an opening or slot 56in the tabbed spacer 26. The tabbed spacer 26 can be fastened to thelooped portion 28 or the tail portions 55, as the case may, through, forexample, heat bonding, an adhesive, a fastener such as a staple, orother suitable mechanism. Preferably, the fastening occurs in theconnecting region 58 of tabbed spacer 26. As mentioned above, the tabbedspacer 26 may include a center aperture 30, which can aid the medicaloperator in the removal of the sleeve 18, as described below. Asindicated in FIG. 5C, the connecting region 58 is preferably locatedbelow the aperture 30, leaving the looped portion 28 (or tail sections55) unattached to the tabbed spacer 26 above the aperture 30.Preferably, the tabbed spacer 26 does not enclose or attach in any wayto the sling 16. Other examples of tab-like structures, which may bepart of the sleeve 18 or an external part, for assisting the separationof the sleeve 18, are disclosed in commonly assigned U.S. patentapplication Ser. No. 10/093,371, the contents of which are incorporatedherein by reference in their entirety. It should be noted that the slingassembly 14 may not require that the sleeve 18 include a tabbed spacer26. In alternate embodiments, the sleeve 18 may include a break orrupture location (not shown), such as a perforation near the center 24,allowing the sleeve 18 to be separated after placement of the sling 16.

FIG. 6 shows an alternative embodiment of a sling delivery system 60. Incontrast to the sling delivery system 10 of FIG. 1, which includes twodelivery devices 12 a and 12 b, the sling delivery system 60 includes asingle delivery device 62. The delivery device 62 includes a handle 64and two delivery legs 66 and 68. As shown, the handle has a proximal end64 a (located closest to a medical operator) and a distal end 64 b(located away from the medical operator. The delivery legs 66 and 68extend from the distal end 64 b of the handle 64 to form a “Y”-shapedconfiguration with the handle 64. The delivery leg 66 has a first sideaperture 70 a near its proximal end 66 a, a second side aperture 72 anear its distal end 66 b, and defines a lumen extending between thefirst side aperture 70 a and second side aperture 72 a. Similarly, thedelivery leg 68 has a first side aperture 70 b near its proximal end 68a, a second side aperture 72 b near its distal end 68 b, and defines alumen extending between the first side aperture 70 b and second sideaperture 72 b. As shown, the sleeve end 18 a threads through the sideaperture 72 a, through the lumen of the delivery leg 66 and out the sideaperture 70 a. Similarly, the sleeve end 18 b threads through the sideaperture 72 b, through the lumen of the delivery leg 68 and out the sideaperture 70 b. The sling assembly employed with the delivery system 60is preferably identical to the sling assembly 14 employed with thedelivery system 10 of FIG. 1. Additionally, as in the case of thedelivery devices 12 a and 12 b, the distal ends 66 b and 68 b of thedelivery legs 66 and 68 may, for example, include end apertures in fluidcommunication with the respective lumens, or alternatively, taper into atip sufficient for piercing and/or tunneling through tissue. For ease ofoperation the sleeve ends 18 a and 18 b may be connected, for example,by knotting them together. For ease of insertion into a surgical site,the distal end 64 b of the handle 64 may be sufficiently flexible toenable the insertion legs 66 and 68 to be squeezed toward each otherduring sling placement, and sufficiently resilient to enable toinsertion legs 66 and 68 to return to their rest orientation subsequentto the medical operator ceasing to apply a squeezing force.Alternatively or in addition, the insertion legs 66 and 68 may besimilarly resiliently flexible.

FIGS. 7A-7C illustrate an exemplary method for delivering and implantingthe sling 16 to an anatomical site in a female patient using thedelivery system 10 of FIG. 1, according to an illustrative embodiment ofthe invention. In the illustrative example, the sling 16 is placed at amidurethral location in the periurethral tissue of the patient. Themethod is described with reference to the sling delivery system 10depicted in FIG. 1, but may be used with the “Y”-shaped delivery system60 depicted in FIG. 6. Specifically referring to FIG. 7A, in theexemplary method, a mid-line incision 72 is made in the vaginal wall 76of a patient, creating an opening 75 underneath the urethra 78. Theseparated vaginal tissues may be held apart by two clips 74, allowingaccess to the urethra 78 through the opening 75. The operator firstintroduces, into the vaginal opening 75, the distal ends 13 a and 13 bof the sling delivery devices 12 a and 12 b, including the slingassembly 14 threaded through the two delivery devices 12 a and 12 b. Theoperator then advances the sling delivery system 10 through the opening75 substantially in the direction indicated by arrows 70 towards theurethra 78. Tunnels in the periurethral tissue may be previously made,or the medical operator may perform the tunneling using delivery devices12 a and 12 b. The middle portion of the sling assembly 14 may beadvanced along with the delivery devices 12 a and 12 b, or may be raisedtowards the urethra 78 later by pulling the sleeve ends 18 a and 18 b.The tab 26 may serve as an indicator of the position of the slingassembly 14 relative to the urethra 78.

Referring now to FIG. 7B, after the operator has passed the slingassembly 14 through the opening 75 in the vaginal wall 76, the distalends 13 a and 13 b of the delivery devices 12 a and 12 b can be movedupward on either side of the urethra 78 from below. Markings may beplaced on the delivery devices 12 a and/or 12 b to assist the operatorin estimating or confirming how far the delivery devices 12 a and/or 12b have advanced and if the sling 16 of sling assembly 14 has reached,for example, the mid-urethral target anatomical site. A marking near thecenter of the sleeve 18 and/or the position of the tab 26 can also helpthe operator decide when the sling 16 has reached the desiredperiurethral tissue for implantation and placement.

To adjust the position of the sling 16 in relation to the target tissue,the operator may manipulate the two delivery devices 12 a and 12 b,and/or pull on the sleeve ends 18 a and/or 18 b. Further, the operatormay guide other medical instruments, such as forceps or scissors (notshown), through the delivery devices 12 a and 12 b into the space 76,for example, to adjust the position of or the tension in the sling 16and/or to cut the sling 16. After the operator is satisfied with theposition of the sling 16, the operator can separate the tab 16, forexample, by cutting across the aperture 30, or otherwise separate thesleeve 18 into two sleeve sections to slide them off the sling 16. Oncethe tabbed spacer 26 is cut, the operator can remove it from the sleeve18 and from the surgical site, such as the vaginal canal.

Still referring to FIG. 7B, after the tabbed spacer 26 is cut, theoperator can slide the sleeve 18 off the sling 16 by pulling the sleeveends 18 a and 18 b. In this way a portion of the sleeve 18 is pulledthrough lumen 36 a and the aperture 40 a of the delivery device 12 a anda portion is pulled through the lumen 36 b and the aperture 40 b of thedelivery device 12 b in the directions indicated by the arrows 80. Tofirmly position the sling 16 in the target anatomical site, e.g., theperiurethral tissues, without requiring additional sutures, the operatormay need to insert or press the distal ends 13 a and 13 b of thedelivery devices 12 a and 12 b deeper into the anatomical site towardthe pubic bone of the patient. The tanged edges 34 of sling 16 will thenembed and anchor in the tissue, so that the sling 16 will remain securedat the anatomical site when the sleeve 18 is withdrawn through thedelivery devices 12 a and 12 b.

The medical operator needs to exercise care that the sling 16 has theappropriate tension to serve its remedial purpose, for example, byproviding needed suspension to the urethra or bladder neck, or byapplying tension to the periurethral tissues, e.g., the urethralsphincter. For example, if there is excessive friction between the sling16 and the interior wall of the sleeve 18, then the sling 16 may beovertensioned and may stretch, causing the sling 16 to wrap too tightlyaround the target periurethral tissues or causing distortion in thesling 16, for example, curling of sides of the sling 16 along itslength. To avoid over-tensioning the sling 16, one or more medicalinstruments, such as a pair of forceps or scissors (not shown), mayinitially be inserted between the urethra 78 and the sling 16 in thespace 76, as discussed earlier. Then, the distal ends 13 a and 13 b ofthe delivery devices 12 a and 12 b may be inserted into the periurethraltissues to wrap the middle portion of the sleeve 18 snugly around theinstrument and the periurethral tissues. Then, either before or aftersliding the sleeve 18 off the sling 16, the medical instrument is alsowithdrawn to provide some slackness to counter any over-tensioningbetween the sling 16 and the periurethral tissue. In any case, theoperator may wish to ascertain that the sleeve 18, with sling 16, isplaced properly around the underside of the urethra 78 before initiatingthe separating and withdrawal of the sleeve 18.

Because the delivery devices 12 a and 12 b are still in place after thesleeve is withdrawn, the operator can use the distal ends 13 a and 13 bof the delivery devices 12 a and 12 b, which preferably are blunt andsolid, to further adjust the tension in the sling 16, for example, bypressing the sling 16 deeper into periurethral tissues after the medicalinstrument that served as a tension buffer is withdrawn. As mentionedabove, the tangs 34 on the mesh sling 16 help to immobilize the sling 16against the periurethral tissue.

Referring now to FIG. 7C, after the operator is satisfied with theplacement of the sling 16 below the urethra 78, the operator withdrawsthe delivery devices 12 a and 12 b from the vaginal canal, leaving thesling 16 in the mid-urethral position shown in FIG. 7C. The operator canthen release the clips 74 and suture up the opening 75 in the vaginalwall 76. Using the device and method of the invention, the operator cancomplete the delivery and placement of the vaginal sling in anexclusively transvaginal fashion without resorting to any abdominalincision or cut.

The above procedure may similarly be performed with the “Y”-shapeddelivery device 60 shown in FIG. 6. In that case, after cutting thetabbed spacer 26 as described above, both segments of the sleeve 18 canbe slid off the sling 16 and withdrawn from the patient simultaneously,in one motion, by pulling the connected ends 18 a and 18 b in thedirection indicated by the arrow 61 while holding the handle 64.However, the ends 18 a and 18 b need not be connected, and even whenconnected, can be pulled out of the respective openings 70 a and 70 bone at a time.

It should be noted that in the procedure of FIGS. 7A-7C, the sling ends16 a and 16 b may be guided, for example, to a location in front of thepubic bone (i.e., to a pre-pubic location) or to a location behind thepubic bone (i.e., a suprapubic location). Additionally, the sling ends16 a and 16 b may fall short of reaching the pubic bone or may extendfar enough to be looped over the pubic bone, in either a pre- orsuprapubic fashion. As discussed below with regard to FIGS. 12A-13, inother illustrative embodiments, each of the sling ends 16 a and 16 b maybe placed near or fed through a respective obturator foramen.

FIGS. 8A-8C illustrate an exemplary method for delivering and implantingthe sling 16 to an anatomical site in a male patient using the deliverysystem 10 of FIG. 1, according to an illustrative embodiment of theinvention. FIG. 8A schematically shows the urogenital region of a malepatient, illustrating the anatomical relationship between the bladder81, the prostate 82, the sphincter 83, and the urethra 84. In theexemplary method, a small incision 86 is made in the perineal area ofthe patient, creating an opening underneath the urethra 84. Referringnow to FIG. 8B and also back to FIG. 1, the operator first introducesinto the incision 86 the distal ends 13 a and 13 b of the sling deliverydevices 12 a and 12 b, including the sling assembly 14 threaded throughthe two delivery devices 12 a and 12 b. The operator then advances thesling delivery system 10 through the incision 86 substantially in thedirection indicated by arrows 88 towards the urethra 84. As describedabove with reference to FIGS. 7A-7C for a female patient, the medicaloperator may perform the tunneling using delivery devices 12 a and 12 b,or tunnels in the periurethral tissue may be previously made. The middleportion of the sling assembly 14 may be advanced along with the deliverydevices 12 a and 12 b, or may be raised towards the urethra 84 later bypulling the sleeve ends 18 a and 18 b. The tabbed spacer 26 may serve asan indicator of the position of the sling assembly 14 relative to theurethra 84. The procedure of implanting the sling 16, includingadjusting the position of the sling 16, adjusting the tension in thesling 16, and sliding the sleeve 18 off the sling 16 subsequent tocutting the tabbed spacer 26 at the level of aperture 30, is similar tothat described above with reference to FIGS. 7A-7C for a female patient.

Referring now to FIG. 8C, after the operator is satisfied with theplacement of the sling 16 below the urethra 84, the operator withdrawsthe delivery devices 12 a and 12 b from the incision 86, leaving thesling 16 in the urethral position shown in FIG. 8C. The operator canthen suture up the incision 86 made in the perineal area. Using thedevice and method of the invention, the operator can complete thedelivery and placement of the sling 16 without resorting to anyabdominal incisions or cuts.

The above procedure may similarly be performed with the “Y”-shapeddelivery device 60 shown in FIG. 6, as described above with reference toFIGS. 7A-7C. Alternatively, the procedure may be performed using otherdelivery device embodiments discussed below with reference to FIGS.9A-13. It should be understood that for the described procedures, andother procedures using the described devices and systems, the deliverydevices and sling may be tailored, for example, in the dimensions of thedevice devices, such as length, diameter, shape, and curvature, slingassembly, such as length and width of the sling or suture thread, for aparticular method of delivery or for placement to a specific anatomicalsite.

FIG. 9 shows an alternative embodiment of a sling delivery system 90with modified delivery devices 96 a and 96 b and a sling assembly 14.Only the delivery device 96 a is shown in FIG. 9A. The delivery device96 b is substantially identical in structure to delivery device 96 a.The sling assembly 14 includes a sling 16 and a sleeve 18. Similar tothe delivery devices 12 a and 12 b of FIG. 1, the delivery device 96 ais formed as a tube or cylinder that defines at least one lumen. In oneillustrative embodiment, a lumen 104 a extends from a radial aperture 98a to an end aperture 106 a. The delivery device 96 a may also tapertowards the distal end 92 a and may terminate as a conical tipsufficient for dilation and tunneling through the tissue. The deliverydevice 96 a may be straight, curved or have a combination of straightand curved sections.

Unlike the delivery devices 12 a and 12 b shown in FIG. 1, the deliverydevices 96 a and 96 b each include cutting devices 110 a, for example,in form of a blade, and can have a handle 100 a. The cutting device 110a is depicted in FIG. 9A and is shown as located inside the lumen 104 a,preferably near the radial aperture 98 a. However, the cutting device110 a and the actuator 102 a may be located in a second lumen extendingbetween the radial aperture 98 a and the end aperture 106 a. The cuttingdevice 110 a is operatively connected to an actuator 102 a and can beoperated by pushing the actuator 102 a towards the handle 100 a.

The sling delivery system 90 may be used for delivering and implantingthe sling 16 to an anatomical site in a patient, both female and male,in a substantially identical process as to that described above withreference to FIGS. 7A to 8C. Once the delivery devices 96 a and 96 b arein position along either side of the urethra and the sling assembly 14is properly positioned in relation to the anatomical site in thepatient, the tabbed spacer 26 is cut to allow sleeve 18 to slide off thesling 16. After a section of the sleeve 18 has been pulled out of thelumen 104 a through the end aperture 106 a in a similar fashion to thatdescribed with respect to sling delivery systems of FIG. 1 and FIG. 5,the sling 16 can be cut by blade 110 a and the delivery devices 96 a and96 b may be withdrawn from the surgical site as before. It is to beunderstood that other surgical instruments, such as forceps or scissors,may also be used during the procedure.

FIG. 10 shows an alternative embodiment of a sling delivery system 121including delivery devices 120 a and 120 b. The second delivery device120 b (not shown) is substantially identical to delivery device 120 a.Delivery device 120 a includes a cutting device 110 a similar to thatdescribed above with reference to FIG. 9. The cutting device 110 a isalso connected to an actuator 102 a extending through the lumen 126 aand operated by pushing the actuator towards the handle 100 a. However,the sleeve 18 is here not threaded through the lumen 126 a, but isinstead threaded through a radial aperture 122 a extending transverselythrough the distal end 93 a of the delivery device 120 a. The slingdelivery system 121 may be used for delivering and implanting the sling16 to an anatomical site in a patient, both female and male, in asubstantially identical process as to that described above withreference to FIGS. 1, 5 and 9. Once the delivery devices 120 a and 120 bare in position along side the urethra and the sling assembly 14 isproperly positioned in relation to the anatomical site in the patient,the tabbed spacer 26 is cut to allow sleeve 18 to slide off the sling16. The sling 16 is depicted as having a suture thread 127 extendingthrough the sling 16. The suture 127 can prevent the sling 16 fromstretching or distorting when the sleeve 18 is slid off sling 16 afterthe tabbed spacer 26 is cut. The operator pulls the separated section ofthe sleeve 18 through the aperture 122 a, and then cuts the sling 16with the blade 110 a. The delivery devices 120 a and 120 b are withdrawnfrom the surgical site as before. In an alternative embodiment, thesleeve 18 may be made from bioabsorbable materials. When sleeve 18 isbioabsorable, sleeve 18 does not include a tabbed spacer 26. The sleeve18 functions to facilitate placement of the sling 16 at an anatomicalsite. After the medical operator determines that the sleeve 18 and thesling 16 are placed as desired, the medical operator may cut the sleeve18 and the sling 16 with the blade 110 a. Although FIG. 10 depicts sling16 as extending substantially the length of the sleeve 18, the sling 16may have a length substantially shorter than the length of the sleeve18. For example, the sling 16 may not be threaded through the aperture122 a and is not cut by the blade 110 a along with sleeve 18.

Use of a bioabsorable sleeve 18 may provide an additional protectionagainst the distorting or deforming of sling 16 by the application oftoo much tension. Examples of bioabsorbable sleeves, and examples ofmaterials for making such sleeves, are disclosed in commonly assignedU.S. patent application Ser. No. 10/631,364, the contents of which areincorporated herein by reference in their entirety. The sling assembliesdescribed herein may be modified to include a bioabsorable sleeve.

FIG. 11 shows another alternative embodiment of a sling delivery system140 with delivery devices 140 a and 140 b and cutting devices 133 a and133 b similar to those depicted in FIG. 10. The delivery devices 140 aand 140 b have radial apertures 148 a and 148 b extending transverselythrough the distal ends 144 a and 144 b of the delivery devices 140 aand 140 b. The sling delivery system 140 includes a sling assembly 141,which includes a sling 152 that, unlike the sling 16, is not enclosed bya sleeve 18. In the exemplary embodiment depicted in FIG. 11, the slingends 16 a and 16 b are attached to respective sutures 157 a and 157 b,which are threaded through the radial apertures 148 a and 148 b of thedelivery devices 140 a and 140 b. For delivering and implanting thesling 16 in a patient, the operator places the delivery devices 140 aand 140 b at the surgical site, as described above with reference toFIGS. 1-10 and adjusts the tension of sling 152 by pulling the sutureends 157 c and 157 d in the direction indicated by arrows 48. When thesling 152 is properly placed, the operator cuts sutures 157 a and 157 bwith the blades 133 a and 133 b, leaving the sling 152 in place.

The sutures 157 a and 157 b can extend over a partial or the entirelength of the sling 152. In such a configuration, the sutures 157 a and157 b can prevent the sling 152 from stretching or distorting when thesling 152 is tensioned from suture ends 157 c and 157 d.

FIG. 12 shows another alternative embodiment of a sling delivery system160 which also uses a sling 168 not enclosed by a plastic sleeve. Thesling 168 is affixed by the sling ends 168 a and 168 b to suturesections 167 a and 167 b. Unlike in the embodiment previously describedwith reference to FIG. 11, the suture sections 167 a and 167 b havefixed lengths and are provided with end connectors 162 a and 162 b. Theslots 164 a and 164 b are disposed on the delivery devices 160 a and 160b near the respective distal ends and releasably engage with endconnectors 162 a and 162 b. The sling 168 loops though a lumen 169 of afastener 166, for example, the ring 166 depicted in FIG. 12. Thefastener 166 may be used to tension the sling from the center portion ofthe sling 168 in contrast to the tensioning methods described abovewhich tension other sling embodiments from the sling ends.

The delivery devices 160 a and 160 b can be formed as tubes orcylinders, and can be straight, curved, or have a combination ofstraight and curved sections. The delivery devices 160 a and 160 b canbe hollow or solid and can have blunt, rounded or conical distal ends.

The medical operator may insert the end connectors 162 a and 162 b intocorresponding slots 164 a and 164 b, or the sling delivery system 160may be supplied preassembled. The medical operator then inserts thedelivery devices 160 a and 160 b into the surgical site in a mannerdescribed above with respect to FIGS. 7A-11. After the sling assembly160 is suitably positioned and anchored in the periurethral tissue, theoperator withdraws the delivery devices 160 a and 160 b from thesurgical site in the direction indicated by arrow 158, thereby alsodisengaging the end connectors 162 a and 162 b from the slots 164 a and164 b. The connectors 162 a and 162 b may disengage from the slots 164 aand 164 b due to friction between the connectors and the body tissues orbe pushed out of the slots 164 a and 164 b by push rods (not shown). Themedical operator can then adjust the length and tension of the sling bypulling the sling 168 through the lumen 169 of ring 166 in the directionindicated by arrow 170. Since the ring 166 and the end connectors 162 aand 162 b remain in the patient's body, they are made of a biocompatiblematerial.

FIG. 13 shows a different embodiment of an end connector, e.g., adilator 176, attached to sling 172 at a junction 173. The dilator 176preferably has the same width as the sling 172, so that the sling 172lies flat when advanced to the surgical site. The dilator 176 can beinserted into the surgical site in the same manner as the connectors 162a and 162 b of the sling assembly 160 of FIG. 12. The exemplary dilator176 depicted in FIG. 13 includes a blind hole 175 into which a needle orrod 174 can be inserted. The rod 174 can be used to push the dilator 176into the periurethral tissue to anchor the sling 172. Optionally, thedilator 176 can also have a recess 177 adapted to mate with a suitabledelivery device. The rod 174 may also include a push tube inside the rod174 or a hollow tube encasing the rod 174 to push the dilator 176 offthe rod 174 to assist in disengaging the dilator 176 from the rod 174.

In a similar fashion to the sling 168 depicted in FIG. 12 and describedabove, the sling 172 is tensioned from the center portion instead offrom its ends by utilizing a ring or other means for adjusting thelength of the sling 172 from its center portion. Since the dilator 176remains in the patient's body, it must be made of a biocompatiblematerial.

Other examples of end portions such as the anchors and dilatorsdescribed above, which may be part of the sleeve 18 or the sling 16, mayinclude suture threads formed into loops or knots. The suture loops orknots may be carried by a knotched distal end of a delivery device andplaced in the desired anatomical site of a patient. The suture loops orknots may be disengaged by withdrawing the delivery device or by using apush rod to disengage the suture loop or knot from the distal end of thedelivery device. Other structures on the distal end of the deliverydevices may also be used to carry the end portions, such as clamps.

Although FIGS. 11-13 illustrated the sling assemblies as sleeve-less, itshould be understood that the sling assemblies described above may bemodified to include a bioabsorbable sleeve. For example, the slingassembly 141, including the sutures 157 a and 157 b, may be enclosed bya bioabsorbable sleeve. In another example, the sling assembly of FIG.13 may also include a bioabsorbable sleeve such that both thebioabsorbable sleeve and the sling 172 is attached to dilator 176 at thejunction 173. In an alternative embodiment, the bioabsorbable sleeve maybe attached to dilator 176 at the junction 173 while sling 16 has freeends and does not attach to anything.

FIG. 14 shows another embodiment of a delivery device 190, whichincludes a handle 192 and a shaft 191 located in a single plane. Likethe delivery device 180, the shaft 191 of delivery device 190 caninclude a proximate aperture 199 and a distal aperture 197 near thedistal end 198. The distal end 198 may also terminate in a conical tip.The apertures 197 and 199 can be connected by a lumen through whichsleeve 18 of sling assembly 14 can be threaded. The distal end 198 ofthe shaft 191 can likewise be provided with connectors as describedabove with respect to the delivery devices 160 a, 160 b, and 174.

A medical operator can use the delivery device 190 for delivering andimplanting the sling 16 to an anatomical site in a female or malepatient. The medical operator creates with the delivery device 190 apassage through body tissue, e.g. for a female patient, from an incisionin the vaginal wall toward the obturator foramen. A first deliverydevice is inserted upward through the vaginal wall at about 45 degreesto the vertical midline of the patient's body. Then the handle is turnedupward and the delivery device is inserted toward, into, or through theobturator membrane. The process is repeated with the second (identical)delivery device on the contralateral side of the body.

As can be seen from the above illustrative description, the invention,according to one feature, provides a simplified procedure with anddelivery device that reduces trauma to the patient, by avoiding anyincisions other than those made in the vaginal wall. The need forcystoscopy is reduced or eliminated because this procedure minimizes thechance of threading the sling through the bladder by accident. Also, byin one embodiment, providing a preassembled delivery system, theinvention further simplifies the procedure for a medical operator andalso reduces potential source of infection from multiple pieces ofequipment to one piece of equipment, which is easier and less expensiveto sterilize and package.

It should also be understood that the delivery devices 190 may bemodified for use with the sling assemblies depicted in FIGS. 11, 12, and13. For example, the delivery device 190, when used with the slingassembly 141, may include an aperture extending through a distal sectionof the distal end 198 through which the suture 157 a of the slingassembly 141 is threaded.

Furthermore, the distal end 198 may include a cutting element and anactuator in the lumen in the distal end 198 and the arm 184 for cuttingthe suture 157 a once the sling 152 is placed as desired.

Variations, modifications, and other implementations of what isdescribed herein will occur to those of ordinary skill in the artwithout departing from the spirit and the scope of the invention asclaimed. Accordingly, the invention is to be defined not by thepreceding illustrative description but instead by the spirit and scopeof the following claims.

What is claimed is:
 1. A system for treating urinary incontinence in apatient, comprising: a first elongated delivery device having a proximalend and a distal end, a first aperture located near the distal end, asecond aperture located near the proximal end, and a lumen extendingbetween the first and second apertures, and a sling assembly including asling and a sleeve, the sleeve defining a lumen, at least a portion ofthe sling being disposed within the lumen defined by the sleeve, thesling assembly having a first end threaded through the first aperture ofthe first elongated delivery device, through the lumen of the firstelongated delivery device and through the second aperture of the firstelongated delivery device, wherein the sleeve includes a memberconfigured to inhibit movement of the sleeve relative to the sling, themember being located on a portion of the sling assembly disposed betweenthe first aperture and a second end of the sling assembly.
 2. The systemof claim 1, wherein the first aperture is located at a termination ofthe distal end of the first elongated delivery device.
 3. The system ofclaim 1, wherein the first aperture is located in a side wall near thedistal end of the first elongated delivery device.
 4. The system ofclaim 1, wherein the sling has a first end that extends into the lumenof the first elongated delivery device.
 5. The system of claim 4,further comprising an operator actuatable cutting device located in thelumen for cutting off a portion of at least one of the sling and thesleeve.
 6. The system of claim 1, wherein the member encloses a loopedportion of the sleeve.
 7. The system of claim 6, wherein the member ischaracterized by a color different than a color characterizing eitherthe sleeve or the sling.
 8. A system for treating urinary incontinencein a patient, comprising: a first elongated delivery device having: aproximal end and a distal end, a first aperture disposed in a sidewallof the first elongated delivery device, the first aperture being locatednear the distal end and disposed proximally from a termination of thedistal end, a second aperture located near the proximal end, and a lumenextending between the first and second apertures, and a sling assemblyhaving first and second ends, at least the first end being operativelyassociated with the distal end of the first elongated delivery device,the sling assembly including a sling and a sleeve, the sleeve defining alumen, at least a portion of the sling being disposed within the lumendefined by the sleeve, wherein the sleeve includes a member configuredto inhibit movement of the sleeve relative to the sling, the memberbeing located on a portion of the sling assembly disposed between thefirst aperture and the second end of the sling assembly.
 9. The systemof claim 8, wherein the sling includes a suture that is associated witha first end of the sling, and at least one of the suture and the firstend of the sling threads through the first aperture located near thedistal end of the delivery device.
 10. The system of claim 9, whereinthe suture passes through the first aperture near the distal end,through the lumen and out the second aperture near the proximal end. 11.The system of claim 8 including an engaging device attached to one ofthe first and second ends of the sling assembly, and a receptacle nearthe distal end of the first delivery device for engaging with theengaging device.
 12. The system of claim 11, wherein the system includesa rod within the lumen of the delivery device to disengage the engagingdevice from the receptacle.
 13. A method for implanting a sling under aurethra in a body of a patient, the method comprising: threading a firstend of a sling assembly through an aperture disposed in a sidewall of adelivery device, the aperture being located near a distal end of thedelivery device and defining an end of a lumen disposed in the deliverydevice, the sling assembly including the sling and a sleeve defining alumen, at least a portion of the sling being disposed within the lumendefined by the sleeve, wherein the sleeve includes a member configuredto inhibit movement of the sleeve relative to the sling, the memberbeing located on a portion of the sling assembly disposed between theaperture and a second end of the sling assembly; inserting the distalend of the delivery device through an incision in a vaginal wall of thepatient to a first side of the patient's urethra to position the firstend of the sling in periurethral tissue on the first side of thepatient's urethra, making no incisions other than to the vaginal wall;disengaging the first end of the sling assembly from the distal end ofthe delivery device; and withdrawing the delivery device.
 14. The methodof claim 13, further comprising removing the sleeve from the sling bycutting the member.